II期j临床试验成功而III期临床失败的案例教训

2019-01-05 黑永疆 同写意

对比中国和美国医药的投资回报率,中国在20%以上,美国只有3%,目前中国的风险没有美国高。 原因是美国创新药多,失败率高;而国内企业的临床试验,一方面是大多数还处于较早期的I期、II期临床阶段,进入III期较少,另一方面这些品类很多都是me-too或me-better,这类产品的临床成功率要高得多。 01临床试验是一个成功率很低的活动 新药临床试验是一个成功率很低的活动,药物从I期临床试

对比中国和美国医药的投资回报率,中国在20%以上,美国只有3%,目前中国的风险没有美国高。 原因是美国创新药多,失败率高;而国内企业的临床试验,一方面是大多数还处于较早期的I期、II期临床阶段,进入III期较少,另一方面这些品类很多都是me-too或me-better,这类产品的临床成功率要高得多。 01临床试验是一个成功率很低的活动 新药临床试验是一个成功率很低的活动,药物从I期临床试验开始要花很多的精力和资源,因此,临床试验失败的成本非常高。 根据数据统计,临床I、II、III期的成功率分别为63.2%、30.7%和58.1%,从下图可见,临床I、II、III期的成功率呈“V”型转折,II期的失败率远远高于I期和III期。 总体看,从I期到上市,临床研究的成功率不到10%,其中肿瘤药的成功率更低。 图1:各阶段临床试验成功率 & 不同适应症III期成功率 02 临床试验失败的主要原因 在不同临床研究阶段,临床试验失败的原因有所不同。 有文献对160个临床I期失败案例和89个临床II期失败案例的原因,从安全性、有效性以及公司策略等方面进行了分析。 发现临床

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    2019-09-27 juliusluan78
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